Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma
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Purpose
RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients will respond to treatment.
PURPOSE: This research study is studying biomarkers in predicting response to rituximab treatment in samples from patients with indolent follicular lymphoma.
| Condition | Intervention |
|---|---|
|
Lymphoma |
Biological: rituximab Genetic: DNA analysis Genetic: gene expression analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: medical chart review |
| Study Type: | Observational |
| Official Title: | Validating the Predictive Value (of Response to Rituximab Induction and Maintenance) of the FCGR3A 158V/F Polymorphism Using Complimentary Genotyping Methods |
- Correlation of FCGR3A 158V/F polymorphisms with response, duration of response, and time to rituximab resistance
- Copy number variation in FCGR3A cohort [ Designated as safety issue: No ]
| Estimated Enrollment: | 259 |
| Study Start Date: | June 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
- Genotype the full cohort of samples available from the RESORT clinical trial (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.
- Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to rituximab resistance.
Secondary
- Quantify copy number variation in FCGR3A in this cohort.
OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms using different complementary genotyping methods. Assay results are reviewed and compared with patients' outcome data.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
- Diagnosed with indolent follicular lymphoma
Treated on RESORT trial (ECOG-E4402) comprising rituximab monotherapy and then randomized to rituximab maintenance therapy or retreatment with rituximab upon disease relapse
- Blood and tissue samples from patients available
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Robert L. Comis, ECOG Group Chair's Office |
| ClinicalTrials.gov Identifier: | NCT01381705 History of Changes |
| Other Study ID Numbers: | CDR0000701978, ECOG-E4402T2 |
| Study First Received: | June 23, 2011 |
| Last Updated: | June 28, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Lymphoma, Non-Hodgkin Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 21, 2013